|Publication number||US7311711 B2|
|Application number||US 10/326,655|
|Publication date||Dec 25, 2007|
|Filing date||Dec 21, 2002|
|Priority date||Dec 21, 2001|
|Also published as||US20030120273|
|Publication number||10326655, 326655, US 7311711 B2, US 7311711B2, US-B2-7311711, US7311711 B2, US7311711B2|
|Inventors||J. Dean Cole|
|Original Assignee||Cole J Dean|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (60), Referenced by (10), Classifications (12), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present disclosure claims the benefit of U.S. Ser. No. 60/342,963 filed Dec. 21, 2001, and which is hereby incorporated by reference.
This invention relates to distractors for use in surgery to repair broken, deformed or damaged bones and joints.
There have been various distractor systems developed, many of which in one form or another utilize a plurality of transfixing and/or half pins which extend through the bone and outward beyond the soft tissue surrounding the bone. The multiple pins are positioned on opposite sides of the fracture and rigidly attached to one or more pin couplings at their distal ends. The pin couplings are interconnected by at least one mounting bar which permits the bone portions located on opposite sides of the fracture to be repositioned relative one another. It is often necessary during surgery to repair broken, deformed or damaged bones and joints to distract tissue segments of interest to provide the proper alignment prior to positioning fixation elements. The distractors that must be utilized to overcome deforming compressive forces of contracted soft tissue may interfere with access to the surgical site in several ways. From a mechanical standpoint, the distraction frame may obstruct physical access to the patient's wound. Furthermore, from a visualization standpoint, the distraction frame may obstruct the surgeon's ability to see the surgical site and the ability to visualize the underlying tissue using X-ray imaging or other devices.
One example of prior art is disclosed in U.S. Pat. No. 4,220,146 to Cloutier, which is incorporated by reference into this Application in its entirety. Such a prior art distractor is illustrated in
The upper and lower pins 102 and 106 are connected to each other on both sides of the femur 107 and tibia 108 by a pair of threaded rods 110 a and 110 b. Mounted to the threaded rod 110 a, is a serrated wheel 112 a. One leg 116 a of an L-shaped member 114 a is rotatedly coupled to the wheel 112 a. The other leg 118 a of the L-shaped member couples to the pin 106. The leg 118 a is pierced by a cylindrical hole extending along its longitudinal axis. The cylindrical hole is of such a diameter as to receive a portion of the rod 110 a in a slidable manner and to guide the same. In a similar manner, an L-shaped member 114 b and wheel 112 b couple the pin 106 to threaded rod 110 b.
Adjustments in the vertical distance between the pins 102 and 106 can be made by turning the wheels 112 a-112 b along the threaded rods 110 a and 110 b. After the pins 102 and 106 are in place, turning the wheels 112 a and 112 b in a downward manner will induce compression stresses within the threaded rods 110 a and 110 b.
Because the rods 110 a and 110 b are relatively slender, the rods flex or buckle under compressive stresses. The buckling causes additional flexural stressed to develop within the rods. Furthermore, threads surrounding the exterior of the threaded rods 110 a and 110 b reduce the effective cross-sectional area of the rods and introduces residual stresses from threading process which further reduces the rod's structure strength.
Thus, there exists a substantial need for an improved distraction device adapted for intra-operative use.
The previously mentioned needs are fulfilled with the present invention. The present invention provides a distraction device that minimizes the obstruction of the surgical site while still providing the necessary distraction features to provide bone fragment alignment and overcome compressive forces of contracted soft tissue. In one aspect, the support member disposed over the surgical site is formed of a material that is substantially radiolucent such that underlying tissue may be readily imaged. Still further, the present invention provides a distractor frame that has an expansion mechanism axially displaced from the surgical site being distracted.
In one aspect of a preferred embodiment depicted herein for the purpose of illustration, there is provided a distractor frame, comprising an upper pin, a lower pin positioned substantially parallel to the upper pin, a pair of adjustment mechanisms, wherein each adjustment mechanism couples to the upper pin and the lower pin such that each adjustment mechanism is positioned generally perpendicular to upper and lower pins, wherein each adjustment mechanism comprises a shaft, a first means coupling the shaft for coupling the upper pin to the shaft, a threaded rod coupled to an end of the shaft, a cylindrical sleeve adapted for threadedly engaging the threaded rod, such that a portion of the shaft and a portion of the threaded rod may be positioned within the cylindrical sleeve, and a second means coupled to the cylindrical sleeve for coupling the lower pin. In a still further preferred aspect, at least the shaft is formed of radiolucent material.
These and other features, and advantages, will be more clearly understood from the following detailed description taken in conjunction with the accompanying drawings. It is important to note the drawings are not intended to represent the only form of the invention.
The principles of the present invention and their advantages are best understood by referring to the illustrated embodiment depicted in
Turning now to
Adjacent the lower end of the main shaft 302 a, there is an expansion mechanism 305 a disposed between rod connector 304 a and 318 a. Coupled to the lower end of the main shaft 302 a, there is a swivel connector 306 a. The swivel connector 306 a couples the main shaft 302 a to a first end 308 a of a threaded rod 310 a. The swivel connector 306 a allows the threaded rod 310 a to rotate with respect to the main shaft 302 a. A drive pattern 312 a maybe fixedly coupled to a second end 315 a of the threaded rod 310 a. The drive pattern 312 a, for example, may be a hexagon head adapted to be rotated by a hand tool. Alternatively, the turning mechanism could be a wheel or handle adapted to be directly rotated by a human hand.
The interior bore of sleeve 316 a is threaded to mate with an exterior threaded surface of the threaded rod 310 a. The interior bore has a diameter which is slightly larger than the exterior diameter of the main shaft 302 a such that cylindrical sleeve 316 a can slidably move in a longitudinal direction with respect to the main shaft 302 a. Similarly, the second pin connector 318 a also has an interior bore which is slightly larger than the exterior diameter of the main shaft 302 a such the second pin connector 318 a may slidably move with respect to rod 302 a. However, the cylindrical sleeve 316 a and second pin connector 318 a may be restrained from free movement by threaded rod 310 a which may be threadedly engaged the cylindrical sleeve 316 a.
The adjustment mechanism 206 b may have identical components to that of adjustment mechanism 206 a, and as such will not be separately described. In one embodiment of the invention all of the components may be formed of medical grade stainless steel. In alternative embodiments, the components may be formed of alternative metals suited for medical applications. In a still further alternative embodiment of the present invention, one or more of the components is formed a material that is substantially passive in the presence of X-rays or energy emitted for nuclear magnetic resonance imaging (MRI). It is contemplated that the components of the device would have limited halo or occlusive effect in generating a visual image with imaging devices. Such materials may include medical grade plastics, composites, polymers, and metals not interfering with imaging devices. It is further contemplated that at least the components adjacent the surgical site be substantially radiolucent.
To illustrate the operation of the above described embodiment, assume the embodiment will be used to treat a fracture or osteotomy fragments of the tibia as illustrated in
As shown in
Moreover, in a more preferred aspect, main shafts 302 a and 302 b are formed of substantially radiolucent material to permit visualization of fracture 402 with imaging equipment. While it is contemplated that the entire distractor may be constructed of radiolucent materials, in one preferred embodiment main shafts 302 a and 302 b are formed of medical grade plastic and the remaining components, including adjustment mechanisms 305 a and 305 b, are formed of medical grade metal. As illustrated in
The turning mechanisms 312 a and 312 b may now be used to precisely adjust the distance between the upper pin 202 and the lower pin 204. For instance, rotating turning mechanism 312 a will also cause the threaded rod 310 a to rotate. Because the cylindrical sleeve 316 a is threadedly engaged with the threaded rod 310 a, the rotation of the threaded rod will cause the cylindrical sleeve 316 a to move longitudinally with respect to the main shaft 302 a. The lower pin 204 is coupled to the cylindrical sleeve 316 a through the pin connector 318 a. Thus, as the cylindrical sleeve 316 a moves with respect to the main shaft 302 a, the lower pin 204 will also attempt to move. Consequently, the rotation of the turning mechanisms 312 a and 312 b may apply traction onto the pins 202 and 204 until they are sufficiently separated to bring the bone fragments to the desired location and/or the ligaments are adequately taut. During this operation, the tension in the patient's ligaments may be checked by conventional methods, such as palpation. Radiographic images may be taken during the distraction process through the main shafts of the distractor frame to monitor the bone fragment distraction and alignment.
It is contemplated that in some applications the pin 202 may be replaced by a wire or cable that extends through a bone portion and is joined to the main shafts by connectors 304 a and 304 b. In this configuration, an additional coupler 360 may be added to end 350 of main shaft 302 a and a similar coupler on main shaft 302 b. A rigid rod may be connected between the two main shafts with the additional couplers 360. Main shaft end 302 a is received in aperture 364 and nut 366 may be turned to tighten the coupler 360 onto the rod interconnecting the main shafts 302 a and 302 b. The interconnecting rod will maintain the relative alignment of the main shafts as force is applied to the flexible wire or cable.
Preferred embodiments of the distractor frame described above may be configured to have several advantages over the prior art, although all advantages may not be meet in different embodiments of the invention. Among other features and not a requirement of for the present invention, the primary structural members comprise a main shaft of substantially uniform diameter rather than a threaded rod. The main shafts 302 a and 302 b may have a greater cross-sectional area, which results in a larger section modulus and ultimately results in a shaft which is more rigid than a threaded rod of the same exterior diameter. The uniform diameter main shaft extending between the primary distractor connectors 304 and 318 provides a greater strength to diameter ratio because there are not surface features that may generate stress risers potentially leading to yielding or failure. Further, additional coupling components (not shown) may be provided to permit the surgeon to perform additional bone alignment procedures off the distractor frame of the present invention. Often bone fragments need to be aligned in multiple planes. Such components may have a uniform size since the diameter of the main shaft is constant along the length between the primary distraction couplers 304 and 318. The uniform diameter main shaft of the present invention also permits the attachment of further couplers to the main shaft without damage to the operation of the distractor, such as bending or deformation of the threads of the shaft that might be experienced in prior devices. Still further, the smooth main shaft permits infinite variability of the distance between the connectors 304 and 318 or any others that may be added later. This provides the distractor system of the present invention with a plurality of configurations to accommodate a wide range of medical indications.
As shown in
Many previous systems had the expansion mechanism that operate at right angles to the application of force. In the illustrated preferred embodiment of the invention, the hex nut is on the end and the surgeon can apply the rotational force directly in line with the axis of distraction. Since the applied force is substantially in axial alignment with the distractor main shaft, it is anticipated that a greater proportion of the applied force is translated into distraction force. Further, the hex nut is disposed on the end of the system making it easier to access and easier to fit a tool to end. A variety of tools can be used to engage the drive pattern including wrenches, ratchets and socket drives. It will be appreciated that the drive mechanism could be modified to an internal print within a socket or a feature that is manually operable without additional tools. Further, the expansion components are axially spaced from the surgical site to permit greater ease of access to the patient's fracture during the distraction procedure.
Although the invention has been described with reference to specific embodiments, these descriptions are not meant to be construed in a limiting sense. Various modifications of the disclosed embodiments, as well as alternative embodiments of the invention will become apparent to persons skilled in the art upon reference to the description of the invention. Moreover, while a preferred embodiment has been described for use in treating a tibia fracture, such illustrative use is instructional only and is not intended to limit the applications of the present invention. By way of example, but without limitation to still further applications, the present invention may be applied to all long bones; heel, ankle and wrist fractures; as well as other joints including the spine, knee and shoulder. It is therefore, contemplated that the claims will cover any such modifications or embodiments that fall within the true scope of the invention.
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|U.S. Classification||606/57, 606/59, 606/54|
|International Classification||A61B17/66, A61F4/00, A61B17/64, A61B17/00|
|Cooperative Classification||A61B17/6408, A61B17/6441, A61B17/66, A61B17/6425|
|Jan 12, 2011||AS||Assignment|
Owner name: SYNTHES USA PRODUCTS, LLC, PENNSYLVANIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:COLE, J. DEAN;REEL/FRAME:025624/0826
Effective date: 20110105
Owner name: SYNTHES USA, LLC, PENNSYLVANIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SYNTHES USA PRODUCTS, LLC;REEL/FRAME:025624/0830
Effective date: 20110110
|May 25, 2011||FPAY||Fee payment|
Year of fee payment: 4
|Jun 10, 2015||FPAY||Fee payment|
Year of fee payment: 8